About Us
Need simple solutions to your quality systems? We have over 40 years of combined experience at dozens of medical device, pharmaceutical and life science companies across the U.S.
A Legacy of Success
Our unwavering commitment to simple but compliant quality solutions drives us to create the best solutions for our clients. We have extensive experience with quality planning, quality system implementation, GMP training, process validation and new product development.
Our experience ranges from startups to fortune 500 companies, at medical device, in-vitro diagnostics, pharmaceutical and life science companies.
At the heart of our success lies a passionate team of seasoned professionals who bring their creativity and expertise to every project. With diverse skills and a shared commitment to excellence, we collaborate to solve your challenges and implement the best practices for your company. We roll up our sleeves and get to work, with new implementations and improvements to meet your quality training, document and consulting needs.
Kathleen Miller
Kathleen is a results-driven and analytical consultant with extensive experience in Quality Systems and Quality Assurance (QA) departments for facilities across the GxP biotechnology, life science and medical device sectors. Equally adept in both individual contributor and leadership roles in quality functions to drive new product development to final release. Compliance-minded with an acuity for fostering transformation by leading through continuous improvement initiatives and change management. Apt communicator, collaborative partner, and empowering leader, aligning with quality teams and propelling performance to deliver on goals and objectives. She is a certified trainer and Distinguished Toastmaster (DTM).
Areas of Expertise Include:
Quality Assurance (QA) | Quality Systems | QMSR | Design Controls | Training | Validation | Quality Control (QC) | Standard Operating Procedures (SOPs) | Technical Writer | CAPA | Contract Manufacturing Organization (CMO) | Program Management | Product Development Research and Development (R&D) | Drug Substances | Medical Device | Manufacturing | Software Testing | Current Good Manufacturing Practices (cGMP) | Six Sigma | Lean | Project Management | Regulatory Compliance | Audit Management | Continuous Improvement | Communication | Cross Functional Collaboration | Team Building | Leadership | Coaching and Facilitation
Michael Bubien
Michael is a Pharmaceutical / Medical Device consultant with over 20 years of industry experience and extensive knowledge of FDA, ISO, MDD, IVDD, CMDR and ICH requirements in both quality assurance and validation engineering roles. He possesses leadership skills in managing complex projects while motivating others to meet ongoing compliance and business needs in rapidly changing environments.
Areas of Expertise Include:
Quality Assurance (QA) | Quality Systems (QS, 21 CFR 210, 21 CFR 211, 21 CFR 820 (QSR and QMSR) , ISO 13485, ISO 9001) | Quality Control (QC) | Regulatory Compliance | Product Development / Design Controls | Verification and Validation (V&V) Testing | Good Manufacturing Practices (cGMP, GxP) | Document Control | Corrective and Preventive Actions (CAPA) | Deviations | Nonconformances | Auditor | Continuous Improvement | Change Control | Technology Transfer | Risk Management (ISO 14971) | FMEA | Hazards Analysis | Process Engineering | Commissioning, Qualification and Validation (CQV) | Equipment Qualification (IQ/OQ/PQ) | Facility / Utility Validation | Process Validation | Test Method Validation (TMV) | Cleanroom Certification | Software Validation | Spreadsheet Validation
Why Choose Us
Simple Solutions
We focus on the fundamentals to deliver simple but compliant solutions that make sense for your business. We can provide some do-it-yourself (DIY) tools, or let us take charge and implement for you.
Expertise
Our team of seasoned professionals brings unmatched QMS expertise to every project. We’ve seen it all, the good and bad, from simple to complex.
Collaboration
We thrive on teamwork, fostering collaborative efforts with your company to meet your specific needs.
Contact Us
just QMS is located in San Diego, California
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